Label: UP AND UP CREAMY DIAPER RASH- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 24, 2012

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  • ACTIVE INGREDIENT

    ZINC OXIDE 13%

    PURPOSE

    SKIN PROTECTANT

  • USES

    HELPS TREAT AND PREVENT DIAPER RASH. PROTECTS CHAFED SKIN DUE TO DIAPER RASH. HELPS SEAL OUT WETNESS.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    CHANGE WET AND SOILED DIAPERS PROMPTLY. CLEAN THE DIAPER AREA AND ALLOW TO DRY. APPLY OINTMENT LIBERALLY AS OFTEN AS REQUIRED WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED.

  • OTHER INFORMATION

    STORE BETWEEN 20-25C (68-77F).

  • INACTIVE INGREDIENTS:

    ALOE BARBADENSIS LEAF JUICE, BEESWAX, DIMETHICONE, ETHYLHEXYLGLYCERIN, FRAGRANCE (PARFUM), MAGNESIUM SULFATE, MICROCRYSTALLINE WAX, MINERAL OIL, PEG-30 DIPOLYHYDROXYSTEARATE, PETROLATUM, PHENOXYETHANOL, POTASSIUM HYDROXIDE, SORBITAN SESQUIOLEATE, TOCOPHERYL ACETATE, WATER (AQUA).

  • QUESTIONS?

    CALL 1-800-910-6874

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    UP AND UP  CREAMY DIAPER RASH
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    APIS MELLIFERA (UNII: 7S82P3R43Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-332-04113.3 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/23/2012
    Labeler - TARGET CORPORATION (006961700)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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